Uses for Focalin XR

Dexmethylphenidate is used to treat attention deficit hyperactivity disorder (ADHD). It belongs to the group of medicines called central nervous system (CNS) stimulants.

Dexmethylphenidate increases attention and decreases restlessness in patients who are hyperactive, cannot concentrate, or are easily distracted. It is used as part of a total treatment program that also includes social, educational, and psychological therapy.

This medicine is available only with a doctor's prescription.

Before using Focalin XR

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of dexmethylphenidate in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies on the relationship of age to the effects of dexmethylphenidate have not been performed in the geriatric population.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nialamide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Desflurane
• Enflurane
• Halothane
• Iobenguane I 131
• Isoflurane
• Methotrexate
• Methoxyflurane
• Risperidone
• Sevoflurane

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, history of or
• Drug abuse and dependence, history of—Dependence may be more likely to develop.

• Bipolar disorder (manic-depressive illness), history of or
• Coronary artery disease or
• Depression, or a family history of or
• Heart disease (eg, cardiomyopathy) or
• Heart rhythm problems (eg, arrhythmia), or a family history of or
• Hypertension (high blood pressure) or
• Priapism (painful or prolonged erection of the penis) or
• Psychosis (mental illness), history of or
• Raynaud's phenomenon (blood vessel disease) or
• Tachycardia (increased heart rate)—Use with caution. May make these conditions worse.

Proper use of Focalin XR

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If you take too much, the medicine may become habit-forming (causing mental or physical dependence).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If you think this medicine is not working properly after you have taken it for several weeks, do not increase the dose. Check with your doctor right away.

This medicine may be taken with or without food.

If you are using the extended-release capsule:

• Take the capsule in the morning. If you take it in the afternoon or evening, you may have trouble falling asleep at night.
• Swallow the capsule whole. Do not crush, divide, or chew it.
• If you cannot swallow the capsule, carefully open it and sprinkle the small beads over a spoonful of applesauce. Swallow the mixture right away without chewing. Do not store the mixture for future use. Do not crush or chew the beads from the capsule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ADHD:
  • For oral dosage form (extended-release capsules):
    • Adults—At first, 10 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
    • Children 6 years of age and older—At first, 5 milligrams (mg) once a day in the morning. Your doctor may adjust your dose as needed. However, the dose is usually not more than 30 mg per day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • Adults and children 6 years of age and older—At first, 2.5 milligrams (mg) 2 times a day, at least 4 hours apart. Your doctor may adjust your dose as needed. However, the dose is usually not more than 10 mg 2 times a day.
    • Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Mixed unused medicine with used coffee grounds or kitty litter, then place it in a sealable bag, empty can, or other container before throwing into the trash. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions while using Focalin XR

It is very important that your doctor check your or your child's progress at regular visits to make sure the medicine is working properly and to decide if you should continue to use it. Blood tests may be needed to check for any unwanted effects.

Do not use dexmethylphenidate together with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Do not start using this medicine during the 2 weeks after you stop an MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, headaches, restlessness, stomach or bowel symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions (seizures).

You or your child will also need to have your blood pressure and heart rate measured before starting this medicine and while you are using it. If you notice any change in your blood pressure, call your doctor right away. If you have questions about this, talk to your doctor.

Dexmethylphenidate may cause serious heart or blood vessel problems. This may be more likely to occur in patients who have a family history of heart disease. Check with your doctor right away if you have chest pain, trouble breathing, or fainting while using this medicine.

Tell your doctor right away if you or your family notice any unusual changes in behavior, such as an increase in aggression, hostility, agitation, irritability, or suicidal thinking or behavior. Also tell your doctor if you or your child see, hear, or feel things that are not there, or have any unusual thoughts, especially if they are new or getting worse quickly.

If you have been using this medicine for a long time and you think you may have become mentally or physically dependent on it, check with your doctor right away. Some signs of dependence may include:

• A strong desire or need to continue using the medicine.
• A need to increase the dose to receive the same effects.
• Withdrawal effects after stopping the medicine, such as irritability, anxiety, unusual tiredness or weakness, nightmares, trouble sleeping or oversleeping, increased appetite, agitation, or slowing of mental and physical activity.

This medicine may cause slow growth and weight loss. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.

If you or your child experience a prolonged or painful erection of the penis for more than 4 hours, check with your doctor right away.

This medicine may cause Raynaud's phenomenon, which is a problem with blood circulation in the fingers or toes. Tell your doctor if you have tingling or pain, a cold feeling, paleness, or skin color changes in the fingers or toes, especially when exposed to cold temperatures. Call your doctor right away if you have unexplained sores or ulcers on your fingers or toes.

Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine on the day you have your surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and especially those for appetite control, asthma, colds, cough, hay fever, allergies, or sinus problems.

Side Effects of Focalin XR

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety

Less common

• Discouragement
• fast, pounding, or irregular heartbeat or pulse
• feeling sad or empty
• fever
• irritability
• lack of appetite
• loss of interest or pleasure
• mood swings
• tiredness
• trouble concentrating
• trouble sleeping

Incidence not known

• Agitation
• arm, back or jaw pain
• black, tarry stools
• bleeding gums
• blood in the urine
• bloody nose
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• chills
• confusion
• cough
• dark urine
• diarrhea
• difficulty in speaking
• difficulty swallowing
• dizziness
• double vision
• drowsiness
• fainting
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• headache
• heavier menstrual periods
• hives, itching, or skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• muscle cramps, pain, stiffness, or spasms
• nausea
• nervousness
• overactive reflexes
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• poor coordination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness, soreness, or itching skin
• restlessness
• right upper quadrant tenderness
• seizures
• severe mood or mental changes
• shivering
• slow speech
• slowed growth in children
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sores, welts, or blisters
• stuffy or runny nose
• sweating
• swollen glands
• talking or acting with excitement you cannot control
• trembling or shaking
• tremor
• troubled breathing with exertion
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• unusual behavior
• unusual bleeding or bruising
• unusual tiredness or weakness
• weight loss
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• bigger, dilated, or enlarged pupils (black part of the eye)
• dry eyes, mouth, nose, or throat
• false or unusual sense of well-being
• feeling of warmth
• holding false beliefs that cannot be changed by fact
• increased sensitivity of the eyes to light
• loss of consciousness
• muscle twitching
• overactive reflexes
• redness of the face, neck, arms, and occasionally, upper chest
• unusual excitement, nervousness, or restlessness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain
• vomiting

Incidence not known

• Hair loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.